TAG:
precision medicine
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
December 29, 2025, Intelligence: Late-Breaking Lab News
The US Department of Veterans Affairs (VA) is expanding its use of precision medicine through a new multi-year contract with Baylor Genetics to provide pharmacogenomic (PGx) and germline genetic testing to veterans across the VA’s nationwide healthcare system. The agreement includes P…
December 8, 2025, Intelligence: Late-Breaking Lab News
For the next 46 months, a Georgia fraudster will stay behind bars after pleading guilty to charges he violated the Anti-Kickback Statute by arranging for medically unnecessary genetic tests. A judge sentenced Patrick C. Moore, Jr. on Dec. 2. Moore was also ordered to pay $7.2 million in…
November 17, 2025, Intelligence: Late-Breaking Lab News
Dealmaking continues in the in vitro diagnostics (IVD) industry as AI-driven genomics and private equity reshape the market for a data-first future. On Nov. 4, Qiagen said it will acquire Parse Biosciences for $280 million to expand its reach into single-cell sequencing, levera…
Deal Offers Signals about the Future of Digital Pathology
THE DIGITAL PATHOLOGY MARKET IS AT AN INFLECTION POINT, AND TEMPUS’ RECENT $81.25 MILLION ACQUISITION OF PAIGE underscores both the challenges and opportunities ahead. While the pandemic temporarily accelerated digital pathology adoption, with vendors raising large su…
Profitable Collaboration with Pharma Companies
CEO SUMMARY: Drug discovery efforts by pharmaceutical companies often need a boost from anatomic pathology practices and clinical laboratories. Forward-thinking lab leaders and pathologists can take advantage of their data and expertise to partner with pharma, setting the …
Workers Use AI More than Lab Leaders Think
CEO SUMMARY: In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show e…
State of Whole Genome Sequencing of Newborns
CEO SUMMARY: Genetic medicine continues to support advances in precision medicine (or personalized medicine, if you prefer). This is true in pediatrics, where several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exom…
Major Events on Horizon to Reshape Lab Market
CEO SUMMARY: Speakers at last month’s Executive War College discussed a range of significant trends and changes happening today in the U.S. healthcare system. Two of the most important trends are …
Pharmacogenetic Tests Deliver for Avera Health Lab
CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians abo…
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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